510(k) K960195 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
THYROCHEK ONE-STEP RAPID TSH ASSAY
| Applicant | Franklin Diagnostics, Inc., Cedar Knolls NJ, US |
| Decision | Substantially Equivalent, Apr 15, 1996 |
| Received | Jan 16, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960195
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.